Sacituzumab Govitecan, Pembrolizumab Effective for Early Triple-Negative Breast Cancer
A combination of sacituzumab govitecan and pembrolizumab appeared safe and efficacious in patients with early triple-negative breast cancer (TNBC), according to research presented at the 2025 ASCO Annual Meeting.
Although pembrolizumab is approved for both early-stage TNBC and metastatic PD-L1 positive TNBC, and sacituzumab govitecan is approved for treating metastatic TNBC, the safety and efficacy of these drugs combined for patients with early-stage disease were not tested until now.
Results from arm one of the NeoSTAR study focusing on neoadjuvant sacituzumab govitecan monotherapy in patients with early TNBC were published last year. This analysis focused on 50 patients who received sacituzumab govitecan combined with pembrolizumab.
All patients had treatment-naive early TNBC and were treated at a dose of 10mg/kg of sacituzumab govitecan on days 1 and 8 of each 21-day cycle. They also received 200 mg of pembrolizumab on day 1 of each cycle. Researchers continued the regimen for a total of four cycles. Then, they performed imaging for residual radiographic disease and performed biopsies if they suspected residual disease. Treating physicians had the option to offer additional neoadjuvant chemotherapy before surgery.
The main outcome was pathologic complete response (pCR). Secondary outcomes were radiographic response, need for chemotherapy, event-free survival, and safety and tolerability.
The pCR rate per the study protocol, which included patients who had a pCR at surgery and did not require chemotherapy, was 34%, or 16 patients.
Two-thirds of the patients experienced a complete or partial radiographic response, with 30% achieving a complete response and 36% achieving a partial response.
Twenty-six patients received additional neoadjuvant chemotherapy, nine of whom experienced a pCR. Half of all patients had attained pCR at surgery.
High-grade adverse events occurred in 40% of patients. The most common adverse events were nausea, alopecia, fatigue, and diarrhea; four patients required dose reductions.
“In the first trial to investigate the sacituzumab govitecan-pembrolizumab combination in early TNBC, 34% of [patients] had pCR. Additional research is needed to determine the optimal duration and sequence of neoadjuvant sacituzumab govitecan-pembrolizumab and chemotherapy for [patients] with TNBC.”
- Rachel Abelman, MD, a medical oncologist at Mass General Cancer Center, and colleagues wrote.
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Disclosures: Abelman declared no financial ties to drug makers. Some authors declared financial ties to drug makers. See abstract for details.
Photo Credit: Getty Images
By Andrew Polhamus
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